MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED MCGRATH; LARYNGOSCOPE, RIGID

Model Number 300-000-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 11/13/2016

Event Type  Injury  

Manufacturer Narrative

Title: soft palate injuries during orotracheal intubation with the videolaryngoscope source: annals of otology, rhinology <(>&<)> laryngology 2017, vol.126(2) 132¿137.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study performed highlighting the risks associated with video laryngoscopes, the device caused laceration of the right tonsil pole on the patient.It was stated that the patient was treated conservatively.

• Brand Name: MCGRATH
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• Manufacturer (Section G): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 9179309
• MDR Text Key: 161956027
• Report Number: 3010244187-2019-00016
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300-000-000
• Device Catalogue Number: 300-000-000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR